Long-term Follow-up of Subjects Treated With CAR T Cells

Marcela V. Maus, M.D.,Ph.D.

Status: Enrolling

Conditions: Long Term Adverse Effects; Adult; CAR-T; Progression-Free Survival; Overall Survival; Disease-Free Survival; Duty to Follow Up

Treatments: Procedure: Tumor Biopsy; Diagnostic Test: Blood test; Diagnostic Test: Disease assessments

Study type: Observational

Funder types: Other

Identifiers

NCT05024175

20-721

Details and patient eligibility

About

This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up study for Phase 1 studies that evaluate the safety and efficacy of CAR T cells: NCT05660369 (DF/HCC# 22-175) and NCT06026319 (DF/HCC# 23-474).

Full description

This is a long-term safety and efficacy follow-up study for subjects who have been treated with CAR T cells in corresponding Phase I main studies that evaluated the safety and efficacy of CAR T cells in subjects.

No investigational treatment will be administered in this study.

The FDA (2020) recommends long-term follow up for subjects treated with gene therapy drug products to monitor for delayed adverse events (AEs), as well as durability of clinical response.

Therefore, after monitoring of subjects in the main studies has been completed (24 months after CAR T cells infusion, or <24 months after CAR T cells infusion if subject terminated early due to disease progression or due to discontinuing corresponding main study for any reason), subjects will be asked to participate in a long-term follow-up study (LTFU).

Subjects will be followed for up to 15 years following their last CAR T cells infusion in the corresponding main study.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects will be asked to participate leading up to the last DF/HCC corresponding main study visit.

Subjects meeting the following criteria are eligible for study participation:

• Provision of voluntary written informed consent by subject
• CAR T cells were administered in DF/HCC IRB corresponding main study

Exclusion criteria

Subjects meeting the following criterion are to be excluded from study participation:

- Subject unable to comply with study requirements

Trial design

45 participants in 1 patient group

CAR T cells

Description:

* Eligibility to participate on this study if enrolled on a DF/HCC IRB corresponding main study and received infusion of CAR T cells * The research study procedures include evaluations and follow up visits: Timepoints of each evaluation and follow up visit- per protocol * Medical History/Physical Exam * Blood Test * Assessment of Disease: CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans. * Tumor biopsy. * Data Collection * Biobanking

Treatment:

Diagnostic Test: Disease assessments

Diagnostic Test: Blood test

Procedure: Tumor Biopsy